CN102428373B - Automatic analysing apparatus and analytical approach - Google Patents
Automatic analysing apparatus and analytical approach Download PDFInfo
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- CN102428373B CN102428373B CN201080021726.3A CN201080021726A CN102428373B CN 102428373 B CN102428373 B CN 102428373B CN 201080021726 A CN201080021726 A CN 201080021726A CN 102428373 B CN102428373 B CN 102428373B
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
- G01N35/00663—Quality control of consumables
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00613—Quality control
- G01N35/00623—Quality control of instruments
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N35/00594—Quality control, including calibration or testing of components of the analyser
- G01N35/00693—Calibration
- G01N2035/00702—Curve-fitting; Parameter matching; Calibration constants
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- G—PHYSICS
- G01—MEASURING; TESTING
- G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
- G01N35/00—Automatic analysis not limited to methods or materials provided for in any single one of groups G01N1/00 - G01N33/00; Handling materials therefor
- G01N35/00584—Control arrangements for automatic analysers
- G01N2035/0097—Control arrangements for automatic analysers monitoring reactions as a function of time
Abstract
The course of reaction data that a kind of basis obtains when measuring the activity degree of the concentration of chemical composition and enzyme are provided, judge accurately abnormal with presence or absence of automatic analysing apparatus and automatic analysis method.By approximation to function course of reaction data, calculate the characteristic quantity of the shape facility of the curved portion representing initial reaction stage.The shape facility amount obtained is used to judge abnormal presence or absence.
Description
Technical field
The present invention relates to the automatic analysing apparatus of the qualitative and quantitative analysis of the biological specimen carrying out blood, urine etc., particularly there is automatic analysing apparatus and the analytical approach of the function of the reaction monitoring clinical examination analytical equipment.
Background technology
The automatic analysing apparatus of clinical examination carries out a certain amount of dispensing to sample and reagent, and to they carry out stirring make it reaction.Through the absorbance of certain hour assaying reaction liquid, ask the concentration and activity value etc. of measured substance according to measurement result.
In the analysis of clinical examination, beyond analytical equipment, need the accuracy control sample etc. that the reagent of each analysis project, the titer for calibration reagent, the state in order to the device in check analysis and reagent and carrying out measure.Thing beyond these devices, obtains final analytical performance by combination.
Factor as the device inside of direct left and right analytical performance can enumerate sampling mechanism, reagent dispensing mechanism, rabbling mechanism, optical system, reaction vessel, calibration cell etc.In addition, the liquid property etc. of reagent, sample, control detection bodies can be enumerated as the factor beyond the device of automatic analysing apparatus etc.
When routine use automatic analysing apparatus, need to confirm these factors, judge whether normally to carry out clinical examination.The confirmation of factor is such as implemented as described below.
(1) calibration of titer is used
Implement to correct to each reagent bottle of projects.Decide initial point by mensuration blank solution and titer, calculate the absorbance of per unit concentration, calculate reduction coefficient (hereinafter referred to as k-factor).Generally, clinical examination technician confirms the rheological parameters' change with time of k-factor, judges the quality of the calibration results.
(2) accuracy control
The known accuracy control sample of concentration is measured afterwards, the difference of confirmation and reference value in calibration.In addition, in the mensuration of patient's detection bodies, results of regular determination accuracy control sample at regular intervals, the deviation of confirmation and allowable value.When having exceeded allowable value, which there occurs problem to check reagent, device.
Repeatedly absorbance is measured, as time series data record in the reaction of sample and reagent.These time series data are also called course of reaction data.The confirmation of the data in current check is carried out by course of reaction data.Its method is different according to analytic approach.The determination method of clinical examination can be divided into rate method and end-point method these 2 kinds according to analytic approach.
Rate method mainly uses when measuring and comprising enzyme component in the sample active, be not measure enzyme self concentration but measure its activity value.Assay method adds a certain amount of matrix as reagent, the key element that mensuration enzyme consumes matrix and changes.Enzyme reaction rate, when substrate concentration height is to a certain degree, moves closer to limit value in theory.Because comprise the matrix of 12 points in the reagent that biochemical project measures, if so the reaction of sample and reagent is normally carried out, then General reactions is relative to time variations, and measured value is also each to be changed with a certain amount of straight line.
In the detection method of the data exception in the past during mensuration in rate method, linear inspection and the ABS limit.That in the analysis project of rate method, checks absorbance to change during test of linearity is linear.Ask the difference of the first half of certain photometric range and later half absorbance variable quantity, be judged as it not being straight line when this difference exceedes the test of linearity value of specifying.In addition, when the concentration of sample measured or enzymatic activity value abnormal high, exceeded reagent can measurement range when, matrix in reagent or coenzyme all consume before the light-metering time, because absorbance sharply changes can not obtain correct measured value, so the exception of data detected by the setting upper limit of absorbance or the reaction extinction ultimate value (the ABS limit) of lower limit.
End-point method mainly measures the concentration of the composition of the protein, fat etc. that comprise in the sample.The material that composition in sample and reagent reacting generate is because together move closer to a certain amount of, so measured value also together moves closer to certain value with the time with the time.
In the detection method of the data exception in the past during mensuration in end-point method, (prozone) inspection before having.In the reagent of immunoturbidimetry using IgA (immunoglobulin (Ig)) and CRP (CRP) etc., because of the salinity of reagent set composition impact sometimes protein separate out as sediment.Because of this sedimentary impact, the situation that the process data that responds is waved, appears at the latter half in reaction time in fact mostly.Correctly measured value can not be obtained when this waves generation on the light-metering point used in calculating in concentration.Additive process and reaction velocity, than method, have the method sending warning when exceeding the ultimate value of specifying by parameter again to have antibody as its method of inspection.
In addition, as utilizing method with presence or absence of course of reaction data judging exception, such as, be well known that method disclosed in patent documentation 1, patent documentation 2.In the method adopting patent documentation 1, use Chemical Reaction Model to generate sequence data storing it reference time in advance, by the course of reaction data of sample and reference time sequence data compare, be judged to be exception when well-behaved from when large.In the method adopting patent documentation 2, with the function prestored, absorbance change is similar to, according to the absorbance change calculated with approximate function, and the absorbance in fact measured well-behaved from size judge abnormal.
Patent documentation 1: JP 2004-347385 publication
Patent documentation 2: JP 2006-337125 publication
In recent years, due to the raising of the performance of automatic analysing apparatus, even if the detection bodies of use trace, reagent also can carry out high accuracy analysis in various project.On the contrary, because the change etc. of small abnormal, the sample in each portion of device and the delicate character of reagent can not correctly be analyzed sometimes.The automatic analysing apparatus of clinical examination measures at certain intervals and allows the absorbance of solution of sample and reagent reacting, according to this time series absorbance measurement absorbance rate of change, final absorbance.According to the activity value of these data calculating concentrations, enzyme.In course of reaction, automatic analysing apparatus implements sampling, reagent dispensing, stirring, comprises multiple error essential factor in these processes.Particularly so far can not quantitative evaluation stir presence or absence and grade, because there is no judgment standard, so reappearance quality and the presence or absence that measures bad (measured value becomes discontinuous etc., is suspect to be the measured value of some problem) wait evaluation to be fuzzy state.In addition, for the washing water of popping one's head in because of reagent to the dilution of reagent with because of user's mistake, other solution is mixed into situation in reagent etc. to the direct influential essential factor of reaction, need exception to be detected from automatic analysing apparatus to user, supervise the maintenance reexamined with device.
Laboratory technician as the user of automatic analysing apparatus leans on eye exam full response process to be difficult in daily inspection business, even if when measured value is in range of normal value wherein, also likely over sight (OS) abnormal reaction, provides the result that correctness is low.
Following formula is disclosed as Chemical Reaction Model in patent documentation 1.Wherein, t represents the moment, and x represents absorbance, and A0, A1, K are parameters.
(formula 1) x=A0+A1exp (-Kt)
In addition, as absorbance being changed to the function be similar in patent documentation 2, beyond (formula 1), disclose following formula.Wherein, t represents the moment, and x represents absorbance, and A, B, K are parameters.
(formula 2) x=-Kt+B
(formula 3) x=A/ (1+Kt)+B
In rate method, often kind of reaction is only in initial Absorbance versus time curvilinear motion, and while time process, the change of absorbance becomes straight line.In (formula 1) (formula 3) as end-point method, reaction is sharply carried out, and becoming the such course of reaction of normal condition can be similar to accurately.On the other hand, for as rate method, reaction is linearly carried out, and reacted and can not terminate in about 10 minutes of observation, absorbance is until the substrate consumption straight line course of reaction that rises continuously or decline, and there is approximate precision low, reactive difference in change is difficult to the problem distinguished.In (formula 2), the approximate difficulty of the curved portion that the reaction in rate method is initial, the detection shape of curved portion being given to affect to such exception is difficult.
Such as, Fig. 2, Fig. 3 represent the result of the course of reaction data being similar to the inspection item measured with rate method with the formula that (formula 1) represents.Fig. 2 is normal course of reaction data, and Fig. 3 is the artificial course of reaction data occurred when stirring abnormal.Transverse axis 110 represents time process, and the longitudinal axis 120 represents absorbance.In addition, mark 130 represents the absorbance of practical measurement, and curve 140 represents with (formula 1) approximate absorbance change.From Fig. 2, Fig. 3, and the error of the approximate expression of the absorbance data of the 1st is large.In addition, large relative to the approximate error stirring abnormal data relative to side's ratio of the approximate error of normal data in this example embodiment.Therefore, in the previous methods of the size detection error of the known error in basis and approximate expression, abnormal detection is difficult.
In addition, measured value is calculated according to before reaction with the difference of reacted absorbance in end-point method, reaction velocity depends on the concentration of sample hardly, but because of the activity value according to the absorbance variable quantity conversion enzyme of each minute in rate method, so measured value and reaction velocity are with certain rate of change.Thus, by comparing the parameter of the certain sample of concentration as the standard substance to control etc., fully can carry out the evaluation of device performance, but measurement result is in disorder and the data evaluating patient's detection bodies of concentration the unknown are difficult.
Summary of the invention
Above-mentioned problem can be resolved in the following manner, namely, in the concentration or activity degree that are contained in the measured substance in sample measure, the time series data of the measured value of calculating and elapsed time Simultaneously test represents until be gradually to the index of the variation characteristic of straight line, judges abnormal presence or absence according to this index.
In addition, can be resolved in the following manner, namely, in the concentration or activity degree that are contained in the measured substance in sample measure, the time series data of the measured value simultaneously measured by the approximation to function and elapsed time with the parameter being gradually to straight line, use this function to calculate and represent that the value according to this index or above-mentioned parameter judges abnormal presence or absence until be gradually to the index of the shape facility of the absorbance change of straight line.
In addition, can be resolved in the following manner, namely, in the concentration or activity degree that are contained in the measured substance in sample measure, the time series data of the measured value simultaneously measured by the approximation to function and elapsed time with parameter, ask the time second differential of this function to become the tangent line in minimum moment, calculate above-mentioned function representation until be gradually to the index of the shape facility of the absorbance change of this straight line, the value according to this index or above-mentioned parameter judges abnormal presence or absence.
In addition, can be resolved in the following manner, namely, in the concentration or activity degree that are contained in the measured substance in sample measure, when set to comprise with t as determining said determination value when, take x as said determination value, with a, b for parameter, with h (t, be Ψ) multiple parameter Ψ, when being gradually to the function of 0, with x=ax+b+h (t, the time series data of the measured value that approximation to function Ψ) represented and elapsed time measure simultaneously, the value according to parameter a, b, Ψ judges abnormal presence or absence.
That is, the present invention comprises following.
(1) automatic analysing apparatus, is characterized in that: possess: reaction vessel; 1st dispensing unit, dispensing sample in reaction vessel; 2nd dispensing unit, dispensing and the sample be dispensed in reaction vessel carry out the reagent reacted; Agitating unit, recombined sample and reagent in reaction vessel; Determination part, obtains the multiple measuring point data in the course of reaction of sample and reagent; Data processing division, process measuring point data; Storage part, is stored in the function used in data processing division; Efferent, exports the result of data processing division, and data processing division is selected to be stored in one of multiple approximate expressions in storage part and is similar to multiple measuring point data, uses the index obtained from curve of approximation to carry out the abnormality juding measured.
(2) automatic analysing apparatus Gen Ju (1), above-mentioned control part calculates the parameter of approximate expression as These parameters in the mode making the square error of said determination point data and above-mentioned curve of approximation and diminish.
(3) automatic analysing apparatus Gen Ju (1), often kind of combination for inspection item and said sample is determined to be stored in the approximate expression in above-mentioned storage part.
(4) automatic analysing apparatus Gen Ju (1), above-mentioned approximate expression is following one of various:
X=a*t+b+c*exp (-k*t) ... (formula 4)
X=a*t+b+e/ (t+d) ... (formula 5)
X=a*t+b+w/{exp (u*t)+v} ... (formula 6)
X=a*t+b+p*log{1+q*exp (r*t) } ... (formula 7).
(5) automatic analysing apparatus Gen Ju (1), in the curve of approximation that above-mentioned multiple measuring point data are similar to, the tangent line of the above-mentioned curve of approximation when reaction being started is as the 1st straight line, using be gradually to above-mentioned curve of approximation straight line as the 2nd straight line time, in the shape facility amount of following (1) to (4) more than one is used as These parameters, carry out abnormality juding
(1) moment of above-mentioned 1st, the 2nd straight line intersection,
(2) above-mentioned 2nd straight line is gradually to the moment of below predetermined threshold value,
(3) difference of the value of above-mentioned 1st, the 2nd straight line of start time is reacted,
(4) difference of the slope of above-mentioned 1st, the 2nd straight line.
(6) automatic analysing apparatus Gen Ju (5), above-mentioned storage part has the shape facility amount obtained from the course of reaction data normal condition, with the distributed data of the shape facility amount that the course of reaction data from abnormality obtain, apply the shape facility amount of trying to achieve from measuring point data and carry out abnormality juding.
(7) automatic analysing apparatus Gen Ju (5), above-mentioned storage part has the data of the determining type having combinationally used abnormal kind and above-mentioned shape facility amount, and above-mentioned data processing division carries out the judgement of abnormal kind.
(8) automatic analysing apparatus Gen Ju (6), above-mentioned abnormal kind is one of the stirring exception of above-mentioned agitating unit, the dispensing exception of above-mentioned dispensing unit, the abnormal of mentioned reagent.
(9) automatic analysing apparatus Gen Ju (1), above-mentioned abnormality juding carries out with the time interval preset from reaction.
(10) automatic analysing apparatus Gen Ju (1), above-mentioned storage part has index and the shape facility amount of multiple measuring point data, in above-mentioned multiple measuring point data, select the data of specified conditions to carry out above-mentioned abnormality juding.
(11) automatic analysing apparatus Gen Ju (1), above-mentioned storage part has index and the shape facility amount of multiple measuring point data, based on the index of multiple measuring point data and the distribution of shape facility amount, carries out shown abnormality juding.
(12) automatic analysing apparatus Gen Ju (1), the absolute value of the time second differential of above-mentioned curve of approximation is asked to become the tangent line in minimum moment, use above-mentioned tangent line to calculate the index of shown curve of approximation, carry out abnormality juding based on These parameters.
(13) automatic analysing apparatus Gen Ju (12), as above-mentioned approximate expression, be used in t as the moment measuring said determination value, using x as said determination value, using a, b as parameter, using h (t, Ψ) as when comprising multiple parameter Ψ and be gradually to the function of 0 with
x＝ax+b+h(t，Ψ)
The function represented, carries out abnormality juding as These parameters to the time series data with the measured value measured by the elapsed time using parameter a, b, Ψ.
(14) automatic analysing apparatus Gen Ju (1), said determination portion possesses: the light source irradiating light to above-mentioned reaction vessel; Detect the test section through the light of above-mentioned reaction vessel.
(15) a kind of analytical approach, it is the determination part that use obtains the measuring point data in the course of reaction of sample and reagent, the data processing division of process said determination point data, be stored in the analytical approach of the storage part of the function used in above-mentioned data processing division, it is characterized in that: said determination portion obtains the multiple measuring point data in the course of reaction of sample and reagent, above-mentioned data processing division is selected to be stored in one of multiple approximate expressions in above-mentioned storage part and is similar to above-mentioned multiple measuring point data, the index obtained from curve of approximation is used to carry out the abnormality juding measured.
Fig. 4 is medelling when representing the rate analysis of the general 2 liquid methods used, the figure of the absorbance change of reactant liquor.Transverse axis 110 represents the process of time, and the longitudinal axis 120 represents absorbance.Curve 150 represents the change of absorbance.Sample in reaction vessel is first initial mixes (time t0) with the 1st reagent.Then this mixed liquor is cultivated at suitable temperature.Do not have influential subsidiary reaction etc. to carry out to mensuration wavelength around here, add in the moment t1 that subsidiary reaction terminates and stir the second reagent, main reaction starts, and the absorbance measuring wavelength changes in increase or minimizing direction.Main reaction is from moment t1, and the speed of this reaction is not necessarily certain from first, roughly becomes certain (reaction becomes standing state, and the change of absorbance becomes straight line) after (figure, time t2) from sometime.From this reaction until become certain time t1 ~ t2 to be commonly referred to as time delay.
This time delay is because measuring the composition of project and reagent, the situation of stirring, temperature of reaction, the concentration etc. of detection bodies and different.The time delays such as such as γ GT (γ glutamine transferase) and LD (deoxidation dehydrogenasa) are large, and ALP (alkaline phosphatase) and AST (aspartate transaminase) etc. are little for time delay.This is because the activity of enzyme is different different with fluidity, stirring condition etc.Like this because be large reason in the reactivity of sample and reagent time delay, thus by time delay until the suitable degree of time before permanent reaction and curve carries out quantification, the reactivity of this project can be evaluated.
The present invention utilizes the approximate expression obtained from course of reaction data, provide a kind of can continuous print and independent verifying attachment is abnormal in each inspection, reagent is deteriorated, the index of accuracy control.By asking approximate expression with the present invention, by the well-behaved parameter number value from degree etc. of the time of the time delay in the course of reaction of each measurement result and size, evaluation and straight line.Because the parameter-dependent obtained is in reagent and project, whether carry out in the best condition so react using this numerical value as metrics evaluation.And, as used course of reaction data, be not limited to absorbance data etc., also can be used in the value etc. that can measure in course of reaction in addition.
The evaluation method of the application of the invention, not only can evaluate control and titer, and can evaluate the measurement result of patient's detection bodies of concentration the unknown one by one.If the evaluation that can measure each detection bodies, then can ensure the reliability of determination data from the data controlled.About the abnormal factor to course of reaction data influence of device, can check that it is abnormal from daily inspection data, the performance that can contribute to device maintains.
As the impact of stirring, such as, when stirring stopping, reaction velocity changes, and the curve of course of reaction data also changes.In the detection bodies that the concentration controlling detection bodies, titer etc. is known, calculate, monitor the change of course of reaction curve be by inspection through time the performance of rabbling mechanism, the maintenance of device user rabbling mechanism, the necessity of replacing can be informed energetically from automatic analysing apparatus.Quantification can be carried out to the presence or absence and grade evaluating ambiguous stirring, because the course of reaction after the stirring after also being added by supervision the 2nd reagent time delay, the condition of best stirring can be set.Thus, the exception of rabbling mechanism can not only be detected, and can investigate and determine the optimal parameter of each project, often kind of reagent.
Under reagent deterioration, being cleaned water-reducible situation in reagent probe, have influence on reaction velocity.If employing the present invention, because the slow degree of the reaction that can quantize, so can abnormal reaction be detected.Can carry out the evaluation of reagent performance, can carry out the detection of the reagent deterioration that the artificial careless omission in current check causes, the leakage that can prevent the data of mistake from exporting is seen.
Accompanying drawing explanation
Fig. 1 is the figure of the treatment scheme representing the 1st kind of embodiment of the present invention.
Fig. 2 represents that use (formula 1) carries out the figure of the example of approximation to function to course of reaction data under normal circumstances.
Fig. 3 represents that use (formula 1) carries out the figure of the example of approximation to function to the course of reaction data under abnormal conditions.
Fig. 4 is the figure of the outline of the course of reaction data representing rate method.
Fig. 5 is the figure of the outline representing the formation being suitable for automatic analysing apparatus of the present invention.
Fig. 6 is the figure representing the example according to the present invention, course of reaction data having been carried out to approximation to function.
Fig. 7 illustrates the figure to the method that the shape facility of the initial curved portion of reaction quantizes.
Fig. 8 is the figure of the distribution example of the shape facility amount representing the course of reaction curve of trying to achieve according to the present invention.
Fig. 9 represents that the combination for inspection item and reagent type describes the figure of the example of the table of the kind of optimal approximation formula.
Figure 10 represents to describe often kind of abnormal kind for judging the figure of the example of the table of abnormal determining type.
Figure 11 is the figure of the treatment scheme representing the 2nd kind of embodiment of the present invention.
Figure 12 is the figure of the treatment scheme representing the 3rd kind of embodiment of the present invention.
Figure 13 illustrates the figure to the method that the shape facility of the curved portion of initial reaction stage quantizes.
Figure 14 is the figure of the constitute example represented in control part 13.
Embodiment
Embodiment 1
Below, the 1st kind of embodiment that present invention will be described in detail with reference to the accompanying.Fig. 5 represents the figure being suitable for the outline that Biochemical autoanalysis device of the present invention is formed.1 is sampler tray, 2 is reagent discs, 3 is reaction tray, 4 is reactive tanks, 5 is sampling mechanisms, 6 is aspirate mechanism, 7 is rabbling mechanisms, 8 is light-measuring mechanisms, 9 is clean mechanisms, 10 is computing machine (PC), 12 is memory storages, 13 is control parts, 14 is piezoelectric element drivers, 15 is rabbling mechanism controllers, 16 is sample receivers, 17, 19 is disks, 18 is reagent bottles, 20 is freezers, 21 is reaction vessels, 22 is reaction vessel holder, 23 is driving mechanisms, 24, 27 is probes, 25, 28 is bolsters, 26, 29 is cantilevers, 31 is fixed parts, 33 is nozzles, 34 is upper and lower driving mechanisms.In memory storage 12 inventory analysis parameter, each reagent bottle can analysis times, maximum can analysis times, the calibration results, analysis result etc.Being analyzed as follows of sample is stated like that according to the order enforcement of the data processing of sampling, reagent dispensing, stirring, light-metering, the cleaning of reaction vessel, concentration conversion etc.
Sampler tray 1 is controlled via computing machine 10 by control part 13.Sampler tray 1 arranges multiple sample receiver 16 in circumferential arrangement, is sequentially moved to sampling probe 24 times according to analyzed sample.Detection bodies in the sample receiver 16 sample pump linked with detection bodies sampling mechanism 5 injects ormal weight to reaction vessel 21.
Divide the reaction vessel 21 being marked with sample in reactive tank 4, move to the first reagent point of addition.To add with ormal weight and attract from reagent container 18 reagent that with reagent dispensing 6 reagent pumps (not shown) linked of popping one's head in the reaction vessel 21 of movement.Reaction vessel 21 after first reagent adds moves to the position of rabbling mechanism 7, carries out initial stirring.Interpolation-the stirring of such reagent is such as carried out the first ~ four reagent.
Reaction vessel 21 after content is stirred passes through from the light beam that light source sends, and the light-measuring mechanism 8 of absorbance multi-wavelength photometer now detects.The above-mentioned absorbance signal detected enters into control part 13, is transformed to the concentration of detection bodies.In addition, in control part 13, carry out the judgement of the exception according to absorbance simultaneously.
Carried out concentration conversion data be stored in memory storage 12, be presented at be attached to computing machine 10 display device on.The position that above-mentioned reaction vessel 21 after light-metering terminates moves to clean mechanism 9 is cleaned, is supplied to the analysis of next time.
Then, with reference to Fig. 1, the detailed of process abnormal according to absorbance judgement in control part 13 is described.Fig. 1 is the treatment step of the part relevant with abnormality juding represented in control part 13.In addition, Figure 14 represents in control part 13, implements the figure of the constitute example of the part of the process shown in Fig. 1.Input/output module 51, approximate treatment module 52, abnormality juding module 53 connect via data bus 54, mutually can carry out the exchange of data.Input/output module 51 and light-measuring mechanism 8, computing machine (PC) 10, memory storage 12 carry out the exchange of data.In addition, each module can be formed with other hardware, CPU, also can install as software pattern in same CPU.
First, for a certain detection bodies while the mensuration starting a certain inspection item, approximate treatment module in step s 5 52 selects to read the approximate expression of the best corresponding with the combination of inspection item and reagent via input/output module 51 from the multiple approximate expressions representing the time variations being stored in absorbance memory storage 12.As long as select automatically to differentiate according to inspection item and reagent.Such as in advance the function that (formula 4) ~ (formula 7) represents is stored in memory storage 12 as approximate expression.Wherein t represents the time, and x represents absorbance.In addition, a, b, c, d, e, k, p, q, r, u, v, w are parameters.In addition, approximate expression that also can be best using each combination for inspection item and reagent stores as table, utilizes table to select the approximate expression of the best corresponding with the combination of inspection item and reagent.
(formula 4) x=a*t+b+c*exp (-k*t)
(formula 5) x=a*t+b+e/ (t+d)
(formula 6) x=a*t+b+w/{exp (u*t)+v}
(formula 7) x=a*t+b+p*log{1+q*exp (r*t) }
Such as, in advance for the combination of inspection item as shown in Figure 9 with the reagent used, the table 500 of best approximate expression is had to be stored in memory storage 12 by describing.In row 510, describe inspection item, row 520 describe the kind of reagent.Row 530 have the Species of inspection item and reagent the kind of best approximate expression.According to the combination of inspection item and reagent, best approximate expression selected by use table 500 in step s 5.And, the formation that the content of this table can be able to change as user.
But 1 time measured or repeatedly measured average absorbance data and is input to the control part 13 with computing unit from light-measuring mechanism 8 by input/output module 51 in step slo through Simultaneously test for several times absorbance and time.Being used in absorbance in the tonal variation with the reaction of reagent and detection bodies and changing the light of wavelength (predominant wavelength) greatly, in the assay method of 2 wavelength light of the light of wavelength (commplementary wave length) that absorbance has almost no change, the difference of the absorbance of predominant wavelength, the absorbance of commplementary wave length is inputted as absorbance data.In step S15, the absorbance data of input is stored in memory storage 12 by input/output module 51.In step S20, input/output module 51 determines whether to store the absorbance data only needed in following process, when there is no, when storing, process is turned back to S10, until store the data number needed, repeat the input of absorbance data, storage.When storing the data number of needs, step S25 is transferred in process.
In step s 25, as reduced as far as possible in the difference of the time variations of the time variations of absorbance that represents by the approximate expression selected in step s 5 and actual absorbance, approximate treatment module 52 calculates the value of the parameter in formula.Specifically, as measure and the absorbance data stored, the square error of absorbance that calculates by approximate expression diminish as far as possible determine in formula parameter value.Existing least-squares calculation method can be utilized in the calculating of parameter value, but as can be corresponding with various forms of formula method, such as with brachistochrone method calculate square error become minimum parameter value.In the reaction using multiple reagent, after with the addition of the reagent (normally final reagent) causing main absorbance change, the large change of absorbance starts.In this case, only the data be added with after the reagent causing main absorbance change for parameter value calculation.
In order to carry out abnormality detection with the present invention, in step s 25 for normal data, need the absorbance that calculates by approximate expression and actual measurement to the difference of absorbance become fully little.In the approximate expression adopting above-mentioned conventional art, there is the problem of the approximation quality difference of the curved portion of initial reaction stage as shown in Figure 2 and Figure 3 like that.But by using (formula 4) ~ (formula 7), the curved portion at initial stage also can high accuracy approximation.Fig. 6 represents the result of the such as data that use (formula 5) is approximate identical with the course of reaction data shown in Fig. 2.The approximation quality comparing the absorbance data known relative to the 1st with Fig. 2 improves.
Then in step s 30, the numerical value (shape facility amount) representing the feature of absorbance running parameter of the part of the absorbance curve change of initial reaction stage is calculated by approximate treatment module 52.The example of shape facility amount is described with reference to Fig. 7.Transverse axis 110 represents the elapsed time from reaction in the figure 7, and the longitudinal axis 120 represents absorbance.The curve of approximation of the absorbance change that curve 140 expression approximate expression is tried to achieve.Straight line 160 is the tangent lines of curve 140 in reaction start time, and straight line 170 is the asymptotic straight lines of curve 140.In addition, the point 180 on transverse axis 110 represents the moment that straight line 160 and straight line 170 intersect.Point 190 on transverse axis 110 represents that curve 140 is fully gradually to the moment of straight line 170.
Fully asymptotic moment definition is such as pre-determine small value ε, and the difference of curve 140 and straight line 170 becomes the moment being less than or equal to ε.ε as certain value, also correspondingly can set with the amplitude of variation of initial absorbance and absorbance.Such as, can by the value of multiplication by constants in initial absorbance, or the value of multiplication by constants in the difference of initial absorbance and final absorbance is as ε.In addition, the fully asymptotic moment can be defined as predefined small value δ, and the difference of the slope of curve 140 and straight line 170 becomes the moment being less than or equal to δ.In this case, δ as certain value, also correspondingly can set with the slope of straight line 170.Such as can using the value of multiplication by constants on the slope of straight line 170 as δ.
Point 200 on transverse axis represents that the point that straight line 170 and the longitudinal axis intersect, the point 210 on the longitudinal axis represent the point that curve 140 and the longitudinal axis intersect.As shape facility amount, such as, calculate following 4 kinds of values.
(1) moment (being set to Tc) that the point 180 on transverse axis 110 represents
(2) moment (being set to Tl) that the point 190 on transverse axis 110 represents
(3) absorbance represented with the point 200 on the longitudinal axis 120 and the difference (being set to D0) of absorbances represented with point 210
(4) difference (being set to G0) of the slope of straight line 160 and the slope of straight line 170
These values are the values of being carried out by the time delay of the course of reaction data in rate method of curve shape partly quantizing.Such as Tl is equivalent to the length of time delay, Tc, D0, G0 become represent time delay part and rectilinear asymptote well-behaved from the value of size.With these values can process quantitatively in the past people in the size of the time delay that sensuously can capture.
Then in step s 35, abnormality juding module 53 is read in for judging abnormal determining type according to the shape facility amount of trying to achieve in step s 30 from memory storage 12.Use a large amount of normal, abnormal data to define best determining type in advance, such as, the table 600 of the form shown in Figure 10 is stored in memory storage 12.In row 610, describing abnormal kind, describing in row 620 for judging abnormal determining type.In the determining type of row 620, p0 ~ p3, q0 ~ q3, r0 ~ r3, s0 ~ s3, v0 ~ v3 are predetermined constants.In this example embodiment, use 4 values of Tc, Tl, D0, the D1 tried to achieve in step s 35, represent the example differentiated with linear discriminant, but such as also can use other shape facility amount, or the parameter value self in approximate expression.Because the parameter value in approximate expression changes according to shape facility, so also can operation parameter self as shape facility amount.In addition, discriminant may not be linearly, such as, can describe with logical formula.
Below in step s 40, abnormality juding module 53 judges abnormal according to the determining type selected in step s 35.Fig. 8 represent Tl, the D0 tried to achieve from the course of reaction data normal condition Distribution value, from the artificial distribution that Tl, D0 of trying to achieve in course of reaction data abnormal state occur to stir.Transverse axis 310 represents the value of D0, and the longitudinal axis 320 represents the value of Tl.Mark 330 represents the distribution of D0, the Tl tried to achieve from the course of reaction data normal condition, and mark 340 represents the distribution of D0, the Tl tried to achieve from the course of reaction data stirred abnormality.Such as by being normal by the data judging in the left side being positioned at straight line 350, by being positioned at the data judging on right side for abnormal, stirring can be detected abnormal.For judging that abnormal and normal straight line can use the known method of discriminatory analysis etc. to try to achieve.
In step S45, abnormal, the normal result of determination judged in step s 40 is exported from abnormality juding module 53 to computing machine 10.
In above-mentioned steps S35, S40, describe each example needing the kind of the exception judged to use different determining types, but the present invention is not limited to the method.Such as use the existing pattern recognition techniques of neural network etc., use the parameter value of shape facility amount or approximate expression, can once judge normal or abnormal kind.In addition, abnormal kind is not specific, can be judged to be it is abnormal yet.In this case, ask multiple approximate expression parameter, shape facility amount in advance in normal state, ask their distribution.In step s 40, the approximate expression parameter of trying to achieve more in step s 25, the shape facility amount of trying to achieve in step s 30, the approximate expression parameter in above-mentioned normal condition, the distribution of shape facility amount, judge abnormal presence or absence.Such as, the approximate expression parameter calculating and try to achieve in step s 25, the shape facility amount of trying to achieve in step s 30, the horse of distribution of trying to achieve in advance breathe out Lenno Bi Si distance, breathe out Lenno Bi Si distance is more than or equal to certain value be judged to be exception when horse.
In the 1st kind of embodiment described above, describe the example that the process shown in Fig. 1 is carried out in control part 13, but carry out processing in other parts of device also passable.In computing machine (PC) 10, the process of Fig. 1 such as also can be performed as software.In addition, the memory storage of computing machine (PC) 10 inside also can be used as memory storage 12.
In addition, in the 1st kind of embodiment described above, describe the example of use (formula 4) ~ (formula 7) as approximate expression, but the approximate expression that can use in the present invention is not limited to (formula 4) ~ (formula 7).Further generally represent that the formula of such straight line then can use equally with following formula if be gradually to.Wherein comprising with t is the moment, take x as absorbance, and with a, b for parameter, h (t, Ψ) is multiple parameter Ψ, is set to the function being gradually to 0.
(formula 8) x=ax+b+h (t, Ψ)
In the 1st kind of embodiment described above, from the current check of every day or using in the course of reaction data obtained the inspection of the detection bodies of calibration, can detect accurately in inspection each time and stir the various exceptions abnormal, dispensing is abnormal, reagent is abnormal etc.
Embodiment 2
Below, the 2nd kind of embodiment that present invention will be described in detail with reference to the accompanying.Adopt Biochemical autoanalysis device the also with 1st kind of embodiment of the 2nd kind of embodiment the same, the outline of formation represents with Fig. 5.Action beyond control part 13 because the same with the 1st kind of embodiment, so detailed.
Below, with reference to accompanying drawing 11, the detailed of process abnormal according to absorbance judgement in control part 13 is described.Figure 11 is the figure of the treatment step of the part relevant with exception represented in control part 13.And, carrying out symbol additional identical on the treatment step of same treatment with the abnormality juding process in the control part 13 in kind of the embodiment of the 1st shown in Fig. 1.Process from step S5 to step S30 because identical with the process of the step S5 to step S30 from the 1st kind of embodiment shown in Fig. 1, so omit the description.
In step s 110, in memory storage 12, store the approximate expression parameter of trying to achieve in step s 25 and the shape facility amount of trying to achieve in step s 30.In step sl 15, abnormality juding module 53 determines whether to implement abnormality juding.Judge such as can implement at regular intervals to judge with presence or absence of being implemented by the abnormality juding of S115.In this case, specify the time interval of carrying out abnormality juding in advance, investigate the elapsed time after the front abnormality juding of enforcement in step sl 15, be judged as implementing abnormality juding when the elapsed time has exceeded the time interval of setting.
In addition, also abnormality juding can be implemented when often implementing certain number of times and checking.Specifying the interval of carrying out the inspection number of times of abnormality juding in this case in advance, the inspection number of times in step 115 after the front abnormality juding of investigation enforcement, when checking that number of times exceedes the number of times of setting, being judged as implementing abnormality juding.
In addition, also can judge whether to implement abnormality juding by the instruction of user.In this case, abnormality juding module 53 investigates the instruction whether having abnormality juding to implement to computing machine 10 from user in step sl 15, is judged as implementing abnormality juding when there being instruction.
In the step s 120, the approximate expression parameter be stored in step s 110 in memory storage 12, shape facility amount is read in abnormality juding module 53.
In the step s 120, the total data that store can be read in, in addition, also can read in the data meeting specified conditions selectively.When reading in selectively, such as a certain specific check item destination data also only can be read in, or in a certain specific test item, and the value of check result is present in the data in a certain specific scope.In addition, the data of calibration and accuracy control sample can also only be read in.By using the data of specified conditions selectively, more precisely exception can be detected.
In step s 125, according to the approximate expression parameter of reading in the step s 120, shape facility amount, abnormality juding module 53 carries out abnormal judgement.Such as ask read in the step s 120 approximate expression parameter, the distribution of investigation shape facility amount and distribution shape normal condition time whether measure the approximate expression parameter, the distribution of shape facility amount that obtain different, when different, be judged to be exception.The technology of existing statistics calibrating etc. can be utilized in the judgement whether distribution shape is different.Like this, by using multiple data (approximate expression parameter, shape facility amount) to judge, the exception of carrying out being difficult in abnormality juding device and the reagent known in single data can be judged.
In step s 130, which, result of determination is in step s 125 exported from abnormality juding module 53 to computing machine 10.
In the 2nd kind of embodiment described above, from daily inspection, or use in the course of reaction data that obtain in the inspection of calibration and accuracy control sample, the various changes of rabbling mechanism, dispensing mechanism, reagent performance etc. can be detected accurately.In addition, judge relative to using single data (approximate expression parameter, shape facility amount) in embodiment 1, because use multiple data to judge, so the abnormality according to single data judging difficulty can also be detected in the 2nd kind of embodiment.
In addition, in the 2nd kind of embodiment described above, describe the example that the process control part 13 shown in Figure 11 carries out, but also can process by other part of device.In computing machine (PC) 10, the process of Figure 11 such as also can be performed as software.In addition, the memory storage of computing machine (PC) 10 inside also can be used as memory storage 12.
Embodiment 3
The 3rd kind of embodiment of the present invention is described in detail referring to accompanying drawing.Adopt Biochemical autoanalysis device the also with 1st kind of embodiment of the 3rd kind of embodiment the same, the outline of formation represents with Fig. 5.Action beyond control part 13, because the same with the 1st kind of embodiment, is omitted so describe in detail.
Below, in control part 13, the detailed of abnormal process is judged with reference to Figure 12 explanation according to absorbance.Figure 12 is the figure relating to the treatment step of the part of abnormality juding represented in control part 13.And, carrying out the same treatment step processed marks identical symbol with the abnormality juding process in the control part 13 in kind of the embodiment of the 1st shown in Fig. 1.
In the 1st kind of embodiment, employ the function being gradually to straight line as the formula be similar to course of reaction data, but be not particularly limited for approximate function in the present embodiment.The approximate middle function used is shown with (formula 9) at this.Wherein t represents the time, and x represents absorbance,
represent multiple parameter.
(formula 9)
Such as conduct
when using 2 functions of t as shown in (formula 10),
represent a0, a1, a2.
(formula 10)
Process from step S10 to step S25 because identical with the process kind of the embodiment of the 1st shown in Fig. 1, so detailed.In step S210, approximate treatment module 52 asks the moment Tv absolute value that the approximation parameters of trying to achieve in step s 25 is updated to time 2 subdifferential of the formula (hereinafter referred to as approximate expression) in (formula 9) being become minimum (it is desirable to 0).Wherein, at this, start time of reaction is set to the moment 0.In step S220, ask the tangent line of (formula 9) in moment Tv.
Below in step S230, approximate treatment module 52 calculates the numerical value (shape facility amount) of the feature of the expression absorbance running parameter of the part of the absorbance curve change of initial reaction stage.The example of shape facility amount is described with reference to Figure 13.Transverse axis 110 represents the process of the time from reaction in fig. 13, and the longitudinal axis 120 represents absorbance.The curve of approximation of the absorbance change that curve 140 expression approximate expression is tried to achieve.Straight line 160 is tangent lines of the curve 140 in reaction start time, and straight line 410 is the tangent lines of the moment tv tried to achieve in step S220.In addition, the point 420 on transverse axis 110 represents the moment that straight line 160 and tangent line 410 intersect.Point 430 on transverse axis 110 represents the moment Tv tried to achieve in step S210.Point 400 on the longitudinal axis represents that the point that tangent line 410 and the longitudinal axis intersect, the point 210 on the longitudinal axis represent the point that curve 140 and the longitudinal axis intersect.Such as calculate 4 kinds of following values as shape facility amount to use.
(1) moment (being set to Td) that the point 420 on transverse axis 110 represents
(2) moment (Tv) that the point 430 on transverse axis 110 represents
(3) absorbance represented with the point 400 on transverse axis 120 and the difference (being set to E0) of absorbances represented with point 210
(4) difference (being set to H0) of the slope of straight line 160 and the slope of tangent line 410
These values are the values that time delay, curve shape partly quantized to the reaction composition data in rate method.Such as Tv is equivalent to the length of time delay, Td, E0, H0 become represent time delay part and rectilinear asymptote well-behaved from the value of size.With these values can process quantitatively in the past people in the size of the time delay that sensuously can capture.
If shape facility amount Tc, Tl, D0, H0 are replaced into shape facility amount Td, Tv, E0, H0 of the present embodiment by step S35, S40, S45 in the 1st kind of embodiment, then because be and the step S35 in the 1st kind of embodiment, process that S40, S45 are identical, so omit the description.
The course of reaction data obtained when measuring with rate method with the time after together linear change, have the situation being changed to curve once again.Even if the result that the present embodiment also can obtain in this case.
In the 3rd kind of embodiment described above, describe the example that the process control part 13 shown in Figure 12 carries out, but also can process by other parts of device.Such as, in computing machine (PC) 10, the process of Figure 12 also can be performed as software.
As illustrated in the 1st ~ 3rd kind of embodiment, be suitable in automatic analysing apparatus of the present invention, according to the exception of daily check data pick-up unit, reagent etc., can contributing to the performance maintenance of device.
Symbol description
1: sampler tray; 2: reagent disc; 3: reaction tray; 4: reactive tank; 5: sampling mechanism; 6: aspirate mechanism; 7: rabbling mechanism; 8: light-measuring mechanism; 9: clean mechanism; 10: computing machine (PC); 12: memory storage; 13: control part; 14: piezoelectric element driver; 15: rabbling mechanism controller; 16: sample receiver; 17: disk; 18: reagent bottle; 19: disk; 20: freezer; 21: reaction vessel; 22: reaction vessel holder; 23: driving mechanism; 24: probe; 25: bolster; 26: cantilever; 27: probe; 28: bolster; 29: cantilever; 31: fixed part; 33: nozzle; 34: driving mechanism up and down; 51: input/output module; 52: approximate treatment module; 53: abnormality juding module; 54: memory storage; 55: data bus; 110: the axle representing time process; 120: the axle representing absorbance; 130: the mark representing the absorbance measured in each moment; 140: the curve representing the absorbance adopting approximate expression to calculate; 150: medelling represents the curve of the absorbance change adopting rate method; 160: approximate reverse answers the curve of process data, the tangent line of reaction start time; 170: carried out the straight line that curve that course of reaction data are similar to is asymptotic; 180: the point representing the moment that straight line 160 and straight line 170 intersect; 190: represent and carry out the point that curve 140 that course of reaction data are similar to fully is gradually to the moment of straight line 170; 200: the point that straight line 170 and the longitudinal axis 120 intersect; 210: the point that curve 140 and the longitudinal axis 120 intersect; 310: the value representing D0; 320: the axle representing the value of Tl; 330: the mark representing the distribution of D0, Tl of trying to achieve from the course of reaction data of normal condition; 340: the mark representing the distribution of D0, Tl of trying to achieve from the course of reaction data stirred abnormality; 350: identify normal and stir abnormal boundary line; 400: the point that tangent line 410 and the longitudinal axis intersect; 410: time 2 subdifferential of having carried out the curve 140 that course of reaction data are similar to becomes the tangent line of the curve 140 in minimum moment Tv; 420: the point representing the moment that straight line 160 and tangent line 410 intersect; 430: represent that time 2 subdifferential of having carried out the curve 140 that course of reaction data are similar to becomes the point of minimum moment Tv; 500: for the combination of test item with the reagent used, describe the table of best approximate expression; 510: the row describing inspection item; 520: the row describing reagent type; 530: the row describing approximate expression kind; 600: the table often kind of the exception detected being described to decision method; 610: the row describing the abnormal kind of detection; 620: the row describing decision method.
Claims (13)
1. an automatic analysing apparatus, is characterized in that comprising:
Reaction vessel;
1st dispensing unit, dispensing sample in above-mentioned reaction vessel;
2nd dispensing unit, in above-mentioned reaction vessel, the sample of dispensing and institute's dispensing carries out the reagent reacted;
Agitating unit, mixes said sample and mentioned reagent in above-mentioned reaction vessel;
Determination part, obtains the multiple measuring point data in the course of reaction of said sample and mentioned reagent;
Data processing division, process said determination point data;
Storage part, is stored in the approximate expression used in above-mentioned data processing division;
Efferent, exports the result of above-mentioned data processing division,
Above-mentioned data processing division selects one of approximate expression of following formula 4 to the formula 7 be stored in above-mentioned storage part to be similar to above-mentioned multiple measuring point data, uses the index obtained from curve of approximation to carry out the abnormality juding measured,
X=a × t+b+c × exp (-k × t) ... (formula 4)
X=a × t+b+e/ (t+d) ... (formula 5)
X=a × t+b+w/{exp (u × t)+v}...... (formula 6)
X=a × t+b+p × log{1+q × exp (r × t) } ... (formula 7)
Wherein, a, b, c, d, e, k, p, q, r, u, v, w are parameter, and t represents the time.
2. automatic analysing apparatus according to claim 1, is characterized in that: above-mentioned data processing division calculates the parameter of approximate expression as These parameters in the mode making the square error of said determination point data and above-mentioned curve of approximation and diminish.
3. automatic analysing apparatus according to claim 1, is characterized in that: often kind of combination for inspection item and said sample is determined to be stored in the approximate expression in above-mentioned storage part.
4. an automatic analysing apparatus, comprising:
Reaction vessel;
1st dispensing unit, dispensing sample in above-mentioned reaction vessel;
2nd dispensing unit, in above-mentioned reaction vessel, the sample of dispensing and institute's dispensing carries out the reagent reacted;
Agitating unit, mixes said sample and mentioned reagent in above-mentioned reaction vessel;
Determination part, obtains the multiple measuring point data in the course of reaction of said sample and mentioned reagent;
Data processing division, process said determination point data;
Storage part, is stored in the approximate expression used in above-mentioned data processing division;
Efferent, exports the result of above-mentioned data processing division,
Above-mentioned data processing division is selected to be stored in one of multiple approximate expressions in above-mentioned storage part and is similar to above-mentioned multiple measuring point data, uses the index obtained from curve of approximation to carry out the abnormality juding measured,
The feature of described automatic analysing apparatus is:
In the curve of approximation that above-mentioned multiple measuring point data are similar to, the tangent line of the above-mentioned curve of approximation when reaction being started is as the 1st straight line, using be gradually to above-mentioned curve of approximation straight line as the 2nd straight line time, in the shape facility amount of following (1) to (4) more than one is used as These parameters, carry out abnormality juding
(1) moment of above-mentioned 1st, the 2nd straight line intersection,
(2) above-mentioned 2nd straight line is gradually to the moment of below predetermined threshold value,
(3) difference of the value of above-mentioned 1st, the 2nd straight line of start time is reacted,
(4) difference of the slope of above-mentioned 1st, the 2nd straight line.
5. automatic analysing apparatus according to claim 4, it is characterized in that: the distributed data of shape facility amount that above-mentioned storage part has the shape facility amount that obtains from the course of reaction data normal condition and obtains from the course of reaction data abnormality, apply the shape facility amount of trying to achieve from measuring point data and carry out abnormality juding.
6. automatic analysing apparatus according to claim 4, is characterized in that: above-mentioned storage part has the data of the determining type having combinationally used abnormal kind and above-mentioned shape facility amount, and above-mentioned data processing division carries out the judgement of abnormal kind.
7. automatic analysing apparatus according to claim 5, is characterized in that: above-mentioned abnormal kind is one of the stirring exception of above-mentioned agitating unit, the dispensing exception of above-mentioned dispensing unit, the abnormal of mentioned reagent.
8. according to claim 1 or automatic analysing apparatus according to claim 4, it is characterized in that: above-mentioned abnormality juding carries out with the time interval preset from reaction.
9. according to claim 1 or automatic analysing apparatus according to claim 4, it is characterized in that: above-mentioned storage part has multiple These parameters, in above-mentioned multiple measuring point data, select the data of specified conditions, carry out above-mentioned abnormality juding.
10. according to claim 1 or automatic analysing apparatus according to claim 4, it is characterized in that: above-mentioned storage part has multiple These parameters, by the distribution of index of comparing These parameters and try to achieve in normal state, carry out above-mentioned abnormality juding, wherein, These parameters is shape facility amount or approximate expression parameter.
11. according to claim 1 or automatic analysing apparatus according to claim 4, it is characterized in that: ask the absolute value of the time second differential of above-mentioned curve of approximation to become the tangent line in minimum moment, use above-mentioned tangent line to calculate the index of above-mentioned curve of approximation, carry out abnormality juding based on These parameters.
12. automatic analysing apparatus according to claim 11, it is characterized in that: as above-mentioned approximate expression, be used in using t as measure measured value moment, using x as said determination value, using a, b as parameter, using h (t, Ψ) as when comprising multiple parameter Ψ and be gradually to the function of 0 with
x＝ax+b+h(t，Ψ)
The function represented, carries out abnormality juding as These parameters to the time series data with the measured value measured by the elapsed time using parameter a, b, Ψ.
13., according to claim 1 or automatic analysing apparatus according to claim 4, is characterized in that:
Said determination portion possesses:
The light source of light is irradiated to above-mentioned reaction vessel;
Detect the test section through the light of above-mentioned reaction vessel.
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- 2010-05-10 CN CN201080021726.3A patent/CN102428373B/en active Active
- 2010-05-10 WO PCT/JP2010/003150 patent/WO2010134277A1/en active Application Filing
- 2010-05-10 EP EP10777517.3A patent/EP2434292B1/en active Active
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Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101038292A (en) * | 2006-03-14 | 2007-09-19 | 株式会社日立高新技术 | Automatic analyzer |
| CN101059506A (en) * | 2007-05-17 | 2007-10-24 | 上海科华实验系统有限公司 | Full-automatic biochemical analysis method and device |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2010134277A1 (en) | 2010-11-25 |
| EP2434292A4 (en) | 2017-11-22 |
| CN102428373A (en) | 2012-04-25 |
| EP2434292B1 (en) | 2019-12-25 |
| JP2010271095A (en) | 2010-12-02 |
| US20120064636A1 (en) | 2012-03-15 |
| JP5520519B2 (en) | 2014-06-11 |
| US9476893B2 (en) | 2016-10-25 |
| EP2434292A1 (en) | 2012-03-28 |
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